Comparison of Two Different Treat-and-Extend Protocols with Aflibercept in Wet Age-Related Macular Degeneration: Two-Yea
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ORIGINAL RESEARCH
Comparison of Two Different Treat-and-Extend Protocols with Aflibercept in Wet Age-Related Macular Degeneration: Two-Year Results Claudia Taipale . Juha-Matti Lindholm . Kai Kaarniranta . Raimo Tuuminen
Received: February 24, 2020 Ó Springer Healthcare Ltd., part of Springer Nature 2020
ABSTRACT Introduction: To optimize the aflibercept treatand-extend protocol in wet age-related macular degeneration (wAMD) beyond the 1-year interim report. Methods: This 2-year prospective randomized clinical trial included 52 eyes from 52 patients with treatment-naı¨ve wAMD. After the induction phase of three monthly aflibercept injections, patients were randomized 1:1 to two different treat-and-extend protocols. In the Digital features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12006759. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12325020-01312-2) contains supplementary material, which is available to authorized users. C. Taipale J.-M. Lindholm R. Tuuminen (&) Helsinki Retina Research Group, University of Helsinki, Helsinki, Finland e-mail: [email protected] C. Taipale J.-M. Lindholm Department of Ophthalmology, Helsinki University Hospital, Helsinki, Finland K. Kaarniranta Department of Ophthalmology, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland R. Tuuminen Unit of Ophthalmology, Kymenlaakso Central Hospital, Kotka, Finland
treat-and-extend protocol with moderate extensions (T&Em), the treatment interval was extended 1 week at a time up to 12 weeks, and then by 2 weeks up to 16 weeks. In the treatand-extend protocol with rapid extensions (T&Er), the treatment interval was initially extended to 8 weeks, and then by 2 weeks up to 16 weeks. Main outcome measure was the number of given aflibercept injections. Results: At the study end point at 2 years, the mean visual gain from the baseline was 7.9 ± 14.5 letters in T&Em, compared to 10.8 ± 16.5 letters in T&Er protocol (P = 0.726). The mean decrease in central subfield macular thickness was 203.0 ± 167.4 lm in T&Em and 192.3 ± 160.2 lm in T&Er protocol (P = 0.822). Treatment interval was 10.3 ± 3.3 weeks in T&Em and 11.7 ± 3.5 in T&Er protocol (P = 0.164) at the end of year 2. The total number of injections in 2 years was 14.1 ± 3.1 in T&Em and 11.6 ± 2.0 in T&Er (P = 0.002), and the number of injections during the second year was 5.4 ± 1.8 and 4.4 ± 1.4, respectively (P = 0.043). A total of 71% of the eyes in both treatment groups had a dry macula at the study end point. Conclusions: At 2 years, the anatomical and functional responses between the two treatment groups were similar. However, the number of given aflibercept injections was smaller in the rapid extensions protocol. Trial Registration: EU Clinical Trials Register Number, 2015-001394-41/FI
Adv Ther
Keywords: Aflibercept; Anti-vascular endothelial growth factor; Treat-and-extend regimen; Wet age-related macular degeneration Key Summary Points Patients with wA
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